Capabilities
Features
XLung™ Patient Kit
Specifications
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Every second counts when treating critically ill patients.
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Capabilities
Novalung provides extracorporeal circulation and physiologic gas exchange, and is the first ECMO* system to be cleared for long-term use for more than six hours
Acute cardiopulmonary failure
Acute respiratory failure
ECMO-assisted cardiopulmonary resuscitation (ECPR)
Failure to wean from cardiopulmonary bypass (CPB)
The device supports life-threatening conditions
Provides oxygenation
Removes CO (ECCO R)*
Portable Therapy
Safety-Focused
Accurate Delivery
One integrated heart and lung therapy platform
SEE HOW IT WORKS
Features
Focused on Improving Patient Care with ECMO
Reduces the need for intubation
1
Minimizes invasive ventilation
1
Allows mobilization
2
Enables spontaneous breathing
3
Improves survival for patients in cardiac arrest
4
Impacts post-operative recovery
5
Supports complex interventions
6,7
Limits the extent of multi-organ injuries
7
The Novalung system, combined with the innovative XLung™ Patient Kit, may replace mechanical ventilation by enabling extracorporeal gas exchange
The therapy provides clinicians with a robust solution that allows a patient’s lungs time to heal. The patient kit includes a membrane lung, DP3 pump head, and integrated pressure sensors.
Specifications
XLung™ Patient Kit
Oxygenator Specifications
DP3 Pump Head Specifications
Novalung
Specifications
Integrated Pressure Sensor Specifications
Ordering information
Contact Us
Clinical Support
800-323-5188
Our specialists are experts at ECLS*. They provide on-site assistance for our equipment, with instruction, training, and guidance on its use for patient support.
*Extracorporeal Life Support
Technical service
Helping to protect your investment and supporting device performance is our priority. Our trusted technicians take pride in serving our customers.
800-227-2572
Learn how you can innovate patient care
Contact US
CONTACT US
© 2020 Fresenius Medical Care. All Rights Reserved. Fresenius Medical Care, the triangle logo, Novalung, XLung, and x.ellence are trademarks of Fresenius Medical Care Holdings, Inc. or its affiliated companies. All other trademarks are the property of their respective owners. P/N 104317-02 Rev A 10/2020
References
Indications for Use | Trademark and Copyright Notice
Intensive care units
Operating rooms
Cardiac cath labs
Portable therapy
Emergency rooms
Pre-connected standard set
Rapid priming
Pressure sensor technology
Integrated bubble trap
Safety-focused
Pressure-limiting flow control
Low flow precision
Auto set alarm limits
Visual parameter trending
Accurate delivery
Negative pressure limiter
Zero flow mode
Bubble and flow alarms
Pressure and alarm management
Colorful and bright display
Data trending up to four parameters
Optional hard key navigation
Intuitive interface
Two independent battery packs provide up to seven hours of backup power
Support when AC power or DC power is not available, or during backup operation
Batteries have direct pump drive connections
Hot swappable battery packs
Central control unit contains connectors for the pressure sensors, flow sensor, and pump drive
Sensor box
Flexibility to support critically ill patients
Portable console
Deploy in all approved treatment areas of your healthcare center
Intuitive interface
Pressure and alarm management
Hot swappable battery packs
Sensor box
Portable console
Integrated pressure sensors
DP3 pump
Membrane lung
Enhances safety due to elimination of pressure measurement lines
Eliminates risk of air aspiration
Integrated pressure sensors
Simple connection, no calibration needed
Features diagonal pump design for minimal prime volume
Dissipates unwanted heat through innovative design
Offers precise control for low and high flow delivery
DP3 pump
Easy-to-change backup drive included
Features x.ellence heparin coating
— Provides hemocompatibility for
long-term applications
Includes PMP fiber technology
Integrated pressure sensors
Oxygenator with integrated bubble trap
Membrane lung
Ordering information
Oxygenator Specifications
Blood flow rate
Maximum gas flow
Maximum blood side pressure
Maximum gas side pressure
Maximum recommended water pressure
Surface area of the gas exchange membrane
Total priming circuit
Oxygenator static prime
Inlet tubing length
Outlet tubing length
Gas fiber material
Hex material
Hex surface area
1.0-7.0 L/min
0-14 L/min
600 mmHg (80 kPa)
25 mmHg
750 mmHg (100 kPa)
1.9 m (20.45 ft )
605 mL ± 10%
320 mL
182 cm (71.65 in)
187 cm (73.62 in)
Polymethylpentene (PMP)
Polyethylene (PE)
0.45m
2
2
2
Speed 0–10000 rpm
Pressure difference
Tubing fitting
Static prime volume
0–10000 rpm
0–600 mmHg (0–80 kPa)
3/8“
17 mL
DP3 Pump Head Specifications
Measurement range
Dimensions (Width x Height x Depth)
Weight
Power supply
Battery pack
Operation time/battery
Display
Measurements
Flow rate
Novalung
290 x 300 x 369mm (11 x 12 x 15 inches)
26 lb. (12Kg) incl. batteries
100–240 VAC, 50–60Hz, 11–28 VDC
10.8 VDC, 8.64 Ah, 93.3 Wh
120-420 min (120 min @10,000 rpm)
10.4 Touchscreen TFT, Resolution 1024 x 768
1 Flow (-2 to +8 L/min)
3 Pressures (-400 to +400)
1 Air Bubble
0–1.0L/min; ±0.1L/min 1.01–8.0 L/ min;
± 8% of displayed value
Novalung Specifications
Measurement range
Accuracy
-400 mmHg to +400 mmHg
± 1% (-50 mmHg to +50 mmHg)
± 3% (-400 mmHg to -51 mmHg;
+ 51 mmHg to +400 mmHg)
Integrated Pressure Sensor Specifications
Novalung console
Trolley
Compact holder
Flow sensor 3/8"
IPS pressure sensor connecting cable
Infusion stand
Support for backup drive
Battery pack
XLung Kit 230
F30000162
Novalung Sensor Box
Novalung Power Supply
Novalung Control Panel
Novalung Battery Pack (2)
Novalung Pump Drive (2)
AC Power cord
F30000169
F30000175
F38400010
F38350001
F35350001
F38350400
F30000166
32000014
Ordering Information
Kluge, Stefan et al., “Avoiding Invasive Mechanical Ventilation by Extracorporeal Carbon Dioxide Removal in Patients Failing Noninvasive Ventilation.” Intensive Care Medicine 38, no. 10 (October 2012): 1632–1639
1
Abrams, Darryl et al., “Extracorporeal Membrane Oxygenation in Cardiopulmonary Disease in Adults.” Journal of the American College of Cardiology 63, no. 25
(July 2014): Part A 2769–2778
2
Maclaren, Graeme et al., “Contemporary Extracorporeal Membrane Oxygenation for Adult Respiratory Failure: Life Support in the New Era.” Intensive Care Medicine 38, no. 2 (February 2012): 210–220
3
Shin,TG et al., “Extracorporeal Cardiopulmonary Resuscitation in Patients with Inhospital Cardiac Arrest: A Comparison with Conventional Cardiopulmonary Resuscitation.” Crit Care Med 39, no. 1 (January 2011): 1–7
4
Alsoufi, Bahaaldin MD et al., “Survival Outcomes After Rescue Extracorporeal Cardiopulmonary Resuscitation in Pediatric Patients with Refractory Cardiac Arrest.” The Journal of Thoracic and Cardiovascular Surgery 134, no. 4 (October 2007): 952-959.e2
5
Khorsandi, Maziar et al., “Extra-Corporeal Membrane Oxygenation for Refractory Cardiogenic Shock After Adult Cardiac Surgery: A Systematic Review and Meta-Analysis.” Journal of Cardiothoracic Surgery 12, no. 55 (July 2017)
5
Arlt M, Philipp A, Voelkel S, Rupprecht L, Mueller T, Hilker M, Graf BM, Schmid C., “Extracorporeal Membrane Oxygenation in Severe Trauma Patients with Bleeding Shock.” Resuscitation 81, no. 7 (July 2010): 804–809
6
Hughes, Ronson et.al., "Extracorporeal Membrane Oxygenation in Traumatic Injury: An Overview of Utility and Indications." InTech (September 2016)
7
The Novalung System is indicated for long-term (>6 hours) respiratory/cardiopulmonary support that provides assisted extracorporeal circulation and physiologic gas exchange (oxygenation and CO removal) of the patient’s blood in adults with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. These may include:
Failure to wean from cardiopulmonary bypass following cardiac surgery in adult patients
ECMO-assisted cardiopulmonary resuscitation in adults
Caution:
Federal (US) law restricts these devices to sale by or on the order of a physician.
Note:
Read the Instructions for Use for safe and proper use of these devices. The Indications for Use for this device can be found at https://fmcna.com/products/indications-safety-and-warnings.
Capabilities
Features
XLung™ Patient Kit
Specifications
Contact Us
Learn More
®
The Novalung heart and lung therapy system by Fresenius Medical Care is used to treat patients with acute respiratory or cardiopulmonary failure. Now there is an option that gives your patients more time to heal.
XLung Kit
F32000004
2
* Extracorporeal membrane oxygenation
* Extracorporeal carbon dioxide removal
800-405-1321
Our teams focus on troubleshooting so you can focus on your patients
TM
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2
* Extracorporeal Life Support
2
2
*
*Data on file